• Acorda Therapeutics Inc., of Hawthorne, N.Y., presented a meta-analysis of data on 501 multiple sclerosis patients from two clinical trials of Fampridine-SR. In the trials, Fampridine-SR significantly increased the probability of patients increasing their walking speed. The meta-analysis confirmed the clinical meaningfulness of increased walking speed by correlating it with quality-of-life improvements. Fampridine-SR (sustained release 4-aminopyridine) is being studied in a Phase III program.

• Bionovo Inc., of Emeryville, Calif., released mixed results from its double-blind, placebo-controlled, randomized, 217-patient Phase II trial of MF101 in hot flash treatment. The 10-g/day dose was statistically superior to placebo (p=0.05) in reducing the number of hot flashes, while the 5-g/day dose showed a positive trend (p=0.06). MF101, an estrogen receptor beta agonist, also showed a trend toward reducing the severity of hot flashes. The only side effect to increase in MF101-treated patients was diarrhea, and there were no cases of endometrial hyperplasia or uterine cancer. Phase III trials are scheduled to begin in early 2008.

• Can-Fite BioPharma, of Petach Tikva, Israel, successfully completed its long-term preclinical toxicology studies of CF101 in preparation for advanced clinical trials. In addition to its ongoing 250-patient phase IIb study in rheumatoid arthritis, the company has started trials in dry eye syndrome and psoriasis.

• Epeius Biotechnologies Corp., of San Marino, Calif., expanded ongoing clinical trials of Rexin-G to include patients with breast cancer and all types of sarcomas who have failed standard chemotherapy. Rexin-G, a tumor-targeted nanomedicine that's delivered by intravenous infusion, previously was granted orphan drug status in the U.S. in pancreatic cancer.

• Evotec AG, of Hamburg, Germany, reported positive top-line results from its first Phase II trial of EVT 201, a partial positive allosteric modulator of the GABAA receptor complex, in primary chronic insomnia. Results from the 67-patient study showed statistically significant improvements between both doses of EVT 201 (1.5 mg and 2.5 mg) and placebo in the co-primary endpoints of Total Sleep Time and Wake After Sleep Onset. Data also showed that WASO during the second half of the night significantly was reduced, indicating that the product has efficacy in sleep maintenance throughout the night. The company also reported improvements across secondary endpoints, including latency to persistent sleep, and patients reported significant improvements in subjectively assessed quality of sleep. Initial analysis showed the drug did not impair slow wave sleep, and was found safe and well tolerated at both dose levels. Further analysis is ongoing.

• Targeted Genetics Corp., of Seattle, presented additional data from its ongoing Phase I/II trial of anti-TNF-alpha gene therapy tgAAC94 in inflammatory arthritis. In the first three dose-escalation cohorts, 13 percent, 14 percent and 33 percent of patients receiving low, medium and high doses of tgAAC94, respectively, achieved a two-point reduction in swelling 12 weeks after treatment, compared to none in the placebo group. Enrollment in the second three cohorts of the trial is complete, and final data are expected in mid-2008.

• YM BioSciences Inc., of Mississauga, Ontario, said it received a no objection letter from Health Canada to its proposed Phase II trial of nimotuzumab plus irinotecan in colorectal cancer. Nimotuzumab is a humanized monoclonal antibody that targets the epidermal growth factor receptor and is approved for sale in India and China as well as in certain Latin American countries for the treatment of head and neck cancers. YM Biosciences expects enrollment in the first cohort of the 100-patient Canadian trial to take 12 months.